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EC number: 640-964-5 | CAS number: 218451-68-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol
- EC Number:
- 640-964-5
- Cas Number:
- 218451-68-4
- Molecular formula:
- not applicable because UVCB
- IUPAC Name:
- Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol
- Details on test material:
- - Name of test material (as cited in study report): Marlowet 4753
- Physical state: clear, yellowish liquid
- Lot/batch No.: 01/96
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: male 244 - 284 g; female 205 - 223 g
- Fasting period before study: 16 hours
- Housing: 5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1997-09-03 To: 1997-09-18
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: intact skin of dorsolumbar region
- % coverage: approx 10% of total body surface
- Type of wrap if used: gauze dressing and acrylastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water and absorbent paper
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.11 cm³/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations: 0.5, 1, 2, 3, 4, 5, 6 and 24 h after patch removal, and thereafter once daily up to day 14; skin reactions: once daily for 14 days after patch removal; weighing: before treatment (day 0) and surviving animals were reweighed on days 7 and 14 (termination)
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical observations: In each animal a number of clinical-toxicological signs were evaluated. Any changes from the normal condition was noted (increase or decrease) and the degree of severity of any clinical symptoms was assessed.
Skin reactions: After patch removal
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no deaths occurred in the course of the study
- Clinical signs:
- other: no abnormal clinical signs were observed, no signs of erythema and oedema were observed
- Gross pathology:
- no test substance related findings were observed
- Other findings:
- - Potential target organs: not identified
- Other observations: no sex-specific differences were found
Any other information on results incl. tables
Table 1: Number of animals dead and with evident toxicity
Dose |
Mortality (# dead/total) |
Time range of deaths (hours) |
Number with evident toxicity (#/total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
2000 |
0/5 |
0/5 |
0/10 |
n.a. |
0/5 |
0/5 |
0/10 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal dermal dose to rats of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study (limit test) was performed to assess the acute dermal toxicity of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane to the rat according to OECD Guidelines for Testing of Chemicals (1992), Section 4, No. 402, "Acute Dermal Toxicity" (Updated Guideline, adopted 24th Feb 1987).
A group of ten rats (five males and five females) was given a single dermal application of the test substance at a dose level of 2000 mg/kg bodyweight. The liquid test substance was administered undiluted (application volume 2.11 cm³/kg bw). The treated area was covered for 24 hours with gauze which was held in place by a semiocclusive dressing. All animals were killed and examined macroscopically on day 14, the end of the observation period.
There were no deaths and no signs of systemic reaction to treatment. After removal of the dressings 24 hours post applicationem until the end of the observation period no skin irritations were noted. The male rats achieved satisfactory bodyweight gains throughout the study, whereas the female rats showed only minimal bodyweight gains. This effect is not considered to be substance related, because variation of bodyweight in this age/bodyweight range in female rats is a physiological finding. The rats were killed and examined macroscopically on day 14, the end of the observation period. The macroscopical examination revealed no abnormalities.
The acute lethal dermal dose to male and female rats of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was found to be greater than 2000 mg/kg bw.
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